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Biostatistician

posted by: spj_bot

About the Role

Excelya is seeking a skilled Biostatistician to join our dedicated team, where Audacity, Care, and Energy shape our approach to clinical research. This is a fantastic opportunity for professionals looking to contribute their statistical expertise in a collaborative environment that values innovative solutions and fosters professional growth.

As a Biostatistician, you will play a crucial role in designing and analyzing clinical trials, using statistical principles to ensure the integrity and validity of our studies. You will work closely with cross-functional teams to generate insights that drive clinical decision-making and regulatory submissions.

Key Responsibilities:

Job Skills

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Regulatory Affairs Officer - Advertising & Promotional Materials

posted by: spj_bot

About the Job

Excelya is seeking a talented Regulatory Affairs Officer specializing in Advertising and Promotional Materials. At Excelya, we prioritize Audacity, Care, and Energy in our professional endeavors, supporting our mission to deliver high-quality healthcare solutions.

As a Regulatory Affairs Officer, you will play a key role in reviewing and approving promotional materials to ensure compliance with applicable regulations. You will work closely with marketing and medical teams to develop strategies that meet both compliance standards and business objectives, creating impactful messaging for our products.

Main Responsibilities:

  • Provide regulatory guidance on the promotion of pharmaceuticals and/or medical devices in France.
  • Manage the review process for promotional, institutional, and environmental materials produced by pharmaceutical companies.
  • Evaluate and approve promotional content to ensure compliance with the French Public Health Code (CSP) and the recommendations of the French National Agency for Medicines and Health Products Safety (ANSM).
  • Offer expert support for the preparation, submission, and follow-up of promotional materials requiring regulatory validation.

Requirements

About You:

Job Skills

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Statistical Programmer

posted by: spj_bot

About the Role

Excelya is on the lookout for a talented Statistical Programmer to join our dynamic team. We are dedicated to upholding our core values of Audacity, Care, and Energy, and we believe that each member of our team plays a pivotal role in advancing clinical research through precise and insightful statistical analysis.

As a Statistical Programmer, you will leverage your expertise to analyze and interpret complex clinical data, ensuring our studies meet the highest standards of quality and compliance. This role not only allows you to showcase your programming skills but also provides the opportunity to collaborate with a diverse group of professionals committed to making a tangible impact in healthcare.

Key Responsibilities:

Job Skills

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Senior Medical Writer

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Medical affairs. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

  • Act as lead author for a range of regulatory and scientific documents (clinical protocols, Investigator Brochures, CTD modules, informed consent forms, etc.).
  • Coordinate cross-functional input (clinical, regulatory, biostatistics, data management, etc.) to ensure consistency and scientific accuracy of all deliverables.
  • Oversee and review the work of external vendors or contributing writers to ensure quality and compliance.
  • Ensure documents adhere to company SOPs, style guides, and international regulatory standards (EMA, FDA, ICH).
  • Manage timelines, planning, and document reviews efficiently to support submission milestones.

Requirements

About You

Job Skills

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Clinical Innovation Project Manager

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

The Clinical Innovation Project Manager will play a pivotal role in driving innovation within clinical trials, enhancing processes, and implementing best practices to improve study designs and outcomes. This is an excellent opportunity for proactive individuals who are passionate about advancing clinical research through innovative solutions.

Main Responsibilities

Job Skills

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QA officer & RSE

posted by: spj_bot

About the Job

Join Excelya as a Quality & CSR Coordinator, where we value Audacity, Care, and Energy in everything we do. In this role, you will have the unique opportunity to oversee quality management systems and contribute to our Corporate Social Responsibility initiatives, promoting excellence and sustainable practices within our organization.

Your focus will include ensuring compliance with quality standards and regulations while actively participating in CSR programs that align with Excelya's vision for creating lasting positive impacts in our community.

In direct contact with internal teams, suppliers and management, you will structure, lead and improve our Quality Management System while deploying concrete actions in favor of the environment, social and ethics.

In this context, your missions will be as follows:

On the Quality side, you will participate in the management:

  • Updating quality documents (procedures, records, etc.)
  • Qualification of suppliers and monitoring of their commitments
  • Internal audits (from planning to reporting)
  • Gap management and CAPAs, with a real root cause analysis approach
  • Preparation of external audits (customers, ISO, etc.)
  • Monitoring and analysis of quality KPIs to detect drifts and propose solutions

On the CSR side, you will contribute to:

Job Skills

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Manager - Tissue and Cell Bank Activities

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work.
We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

We are looking for a Manager – Tissue and Cell Bank to join our dynamic R&D team and oversee activities related to tissues, fluids, tumors, PDX, organoids, lysates, and subcellular fractions.
In this key position, you will drive the development and evolution of the Tissue and Cell Bank in line with the target R&D organization, ensuring excellence in quality, compliance, and operational performance.

Main Responsibilities:

Job Skills

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CMC Project QA manager (Dry forms)

posted by: spj_bot

About the Job

At Excelya, we embody Audacity, Care, and Energy. We are seeking a dedicated CMC Project Quality Insurance professional to join our team, where you will be instrumental in ensuring quality throughout the CMC (Chemistry, Manufacturing, and Controls) processes. This role provides an exceptional opportunity to work in a supportive environment that prioritizes collaboration and innovation.

In this position, you will work closely with cross-functional teams to uphold the highest quality standards for our CMC projects, facilitating compliance with regulatory requirements and contributing to the overall success of product development.

Main Responsibilities

Job Skills

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Slovak Speaking Customer Service for Pharmaceuticals industry

posted by: spj_bot

Mercier Consultancy MD is thrilled to offer an exciting opportunity for Slovak Speaking Customer Service Representatives in the Pharmaceuticals industry. This role is perfect for individuals who are passionate about healthcare and dedicated to providing outstanding service to clients. In this position, you will interact with customers in Slovak, assisting them with inquiries related to pharmaceutical products and services.


Key Responsibilities

  • Handle customer inquiries related to pharmaceutical products, services, and prescriptions via phone, email, and live chat in Slovak.
  • Provide accurate information on product availability, usage, and health recommendations.
  • Assist customers with order processing, tracking, and returns.
  • Resolve customer complaints and issues promptly to ensure customer satisfaction.
  • Document all customer interactions accurately and maintain records in the CRM system.
  • Collaborate with healthcare professionals and internal teams to enhance service delivery.
  • Stay informed on industry regulations, product updates, and best practices to effectively support customers.

Requirements

Job Skills

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Documentary System Project Manager R&D

posted by: spj_bot

About the Job

Join Excelya as a Business Expert: Documentary System Project Manager and take a leading role in the transformation of clinical research documentation processes across our organization. You will spearhead initiatives aimed at enhancing our documentary systems, ensuring compliance with regulatory requirements, and improving operational efficiency.

In this strategic position, you will engage with various stakeholders to gather requirements, analyze current processes, and implement innovative solutions that streamline project activities.

Main Responsibilities:

Are you passionate about digital transformation and regulatory excellence in R&D?

We’re looking for a Document Management & Systems Lead to manage and optimize the document management platforms, ensuring high standards of compliance and efficiency.

You’ll act as the bridge between science, quality, and technology, leading key projects that shape the future of documentation in pharmaceutical research.

1) Functional administration:

• Functional administration of the databases

• Follow up of issues and improvements

• Management of evolution and releases as Business Expert

• Follow-up of the system validation status

• Redaction of SOP and training materials

• User assistance

Job Skills

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